From the FDA Drug Label
WARNINGS Liver warning: This product contains acetaminophen. Severe Liver damage may occur if you take Allergy alert: acetaminophen may cause severe skin reactions DIRECTIONS ... under 18 years of age • ask a doctor ... children under 12 years • do not use
The risks associated with using Tylenol (acetaminophen) in infants include:
- Severe liver damage
- Severe skin reactions
- The drug label advises to ask a doctor for use under 18 years of age and to not use for children under 12 years, implying a potential risk for this age group 1, 1, 1
From the Research
Risks Associated with Tylenol (Acetaminophen) in Infants
- The use of paracetamol (acetaminophen) in infants has been widely believed to be safe, but increasing evidence suggests that early life exposure may cause long-term neurodevelopmental problems 2.
- A systematic review found that although paracetamol is not associated with acute liver damage in babies or children when used as directed, its safety for neurodevelopment has never been proven 2.
- Studies have shown that paracetamol toxicity can occur in children, particularly in cases of intentional overdoses or unintended inappropriate dosing 3.
- A narrative review highlighted the risk of paracetamol overdose in newborns and infants, which can result in hepatotoxicity and require treatment with N-acetylcysteine 4.
- Research has also shown that parents often misdose acetaminophen and ibuprofen, which can lead to unintended toxicity or inadequate symptomatic improvement, with infants under 1 year old being more likely to receive an inaccurate dose 5.
- A Cochrane review found that paracetamol does not significantly reduce pain associated with heel lance or eye examinations in neonates, and its use may even increase the response to later painful exposures 6.
Specific Risks
- Neurodevelopmental problems: increasing evidence suggests that early life exposure to paracetamol may cause long-term neurodevelopmental problems 2.
- Hepatotoxicity: paracetamol overdose can result in hepatotoxicity in newborns and infants, particularly in cases of supratherapeutic doses 4.
- Inaccurate dosing: parents often misdose acetaminophen, which can lead to unintended toxicity or inadequate symptomatic improvement 5.
- Lack of efficacy: paracetamol may not be effective in reducing pain associated with certain procedures, such as heel lance or eye examinations 6.